Posted on 07/02/2023 3:13:20 PM PDT by george76
Now that the pandemic has ended, researchers are urging regulatory agencies to consider the safety issues associated with the rapid approval of COVID-19 vaccines—and to correctly classify messenger RNA (mRNA) vaccines as gene therapy products (GTPs) to prevent pharmaceutical companies from bypassing regulatory standards.
According to a paper published in the International Journal of Molecular Sciences on June 22, COVID-19 mRNA vaccines, by mode and action, are gene therapy products and should adhere to different regulatory standards. Yet U.S. and European regulatory agencies have not classified COVID-19 mRNA vaccines as gene therapy products, which has allowed them to be regulated as vaccines against infectious diseases instead of being subjected to the more stringent regulation of GTPs.
Because current regulatory guidelines either do not apply, do not mention RNA therapeutics, or do not have a widely accepted definition for these products, regulatory agencies adopted a modified and accelerated approval process for COVID-19 vaccines in the form of a “rolling review.”
A rolling review is a regulatory tool typically used during a public health emergency to speed up the assessment of data for medicines or vaccines. It allows data to be reviewed as it becomes available—without the complete data package or specific controls.
This process led to broad and continuous biodistribution of mRNA COVID-19 vaccines that were not thoroughly studied and yielded tests with noncompliant results regarding purity, quality, and batch homogeneity. Manufacturers are now planning to replace classic vaccines with mRNA vaccines using the same process—starting with influenza vaccines.
Vaccines With mRNA Technology Are Gene Therapies..
The Centers for Disease Control and Prevention currently defines a “vaccine” as a preparation used to stimulate the body’s immune response against diseases. However, the agency’s definition was changed in 2021 out of concern it didn’t apply to COVID-19 vaccines.
A vaccine must contain an antigen to trigger the body’s natural immune response. Pfizer and Moderna’s mRNA vaccines do not contain antigens. The active substance used to elicit an immune response in these vaccines is the mRNA—a form of nucleic acid and the genetic material of the SARS-CoV-2 virus that provides instructions to the body for producing antigens—spike proteins.
In other words, the mRNA is not the substance causing active immunization. Instead, the mRNA must be translated into protein by the cells of the person vaccinated, and that person’s immune system must produce its own antigens to trigger an immune response.
The U.S. Food and Drug Administration (FDA) states that gene therapy seeks to “modify or manipulate the expression of a gene or to alter the biological properties of living cells for therapeutic use.” Moderna’s Q2 2020 filing with the Securities and Exchange Commission acknowledged that mRNA is “considered a gene therapy product by the FDA.” In addition, BioNTech founder Ugur Sahin, in a 2014 article stated, “One would expect the classification of an mRNA drug to be a biologic, gene therapy, or somatic cell therapy.”
According to the FDA, mRNA vaccines are comparable to the TypeIA of prodrugs—substances that, after administration, are converted in the body into pharmacologically active drugs.
This “prodrug property” could suggest that additional controls should be applied in addition to those required for vaccines. However, neither the FDA nor the European Medicines Agency (EMA) have referenced these qualifications for mRNA COVID-19 vaccines.
“With a conventional vaccine, you have the antigen, and you inject it into a person, and that is the thing that your immune system looks at and says, ‘ah ha,’ we need to make antibodies, T-cells, and other immune system components to what’s being injected,” said Dr. David Wiseman, a research scientist with a background in pharmacy, pharmacology, and experimental pathology, in an interview with The Epoch Times.
“The prime reaction of an mRNA vaccine is that it instructs the body how to make the antigen of interest. So, it’s similar to a prodrug, which is converted inside the body via metabolism and enzymes into the desired drug effect. The substance you’re injecting isn’t doing the final action; it leads to the thing that does the final action. With a prodrug, the molecule you inject does not get changed into the final molecule of the antigen, it simply provides instructions because it’s gene therapy.”
Wiseman said the FDA and EMA guidance and regulations that discuss gene therapy all define gene therapies “more or less” the same way. However, a number of years ago, the FDA decided to exclude vaccines for infectious diseases from its various guidance for unknown reasons, including vaccines made from gene therapy technology. Vaccines, in essence, were given their “own set of rules.”
However, the FDA can “change or exclude whatever they want from regulatory guidance, but it doesn’t change the biologic definition of the product,” said Wiseman. “Since Pfizer and Moderna COVID-19 vaccines meet the definition of gene therapy, they should be handled according to gene therapy guidelines.”
mRNA COVID-19 Vaccines Bypassed Essential Studies..
According to the paper, because mRNA COVID-19 vaccines were not classified as gene therapy, necessary tests required for GTPs were not performed for the following:
Genotoxicity.
Genome integration.
Germ-line transmission.
Insertional mutagenesis.
Tumorigenicity.
Embryo/fetal and perinatal toxicity.
Long-term expression.
Repeated toxicity.
Excretion in the environment, such as shedding through seminal fluid or breast milk.
“The long-term safety monitoring of GTPs is required over several years whereas, for vaccines, it is generally only carried out over a few weeks,” wrote Dr. Helene Banoun with the French Institute of Health and Medical Research in the paper. “This should not be acceptable, given the persistence of the drug product and the expressed protein.”
In addition, known results of anti-cancer therapies that use gene therapy technology and mRNA vaccines could lead us to anticipate safety and efficacy problems, she added.
In the EU, gene therapy medicinal products are required to undergo “tests or trials to evaluate the risk of genome integration and germ-line transmission, even if this integration is unlikely,” and tests and clinical trials to evaluate the risk of “insertional mutagenesis, tumorigenicity, embryo/fetal and perinatal toxicity, and long-term expression.”
EMA requires “extensive studies on both the nucleic acid and the vector particle/delivery system that includes biodistribution, dose study, potential target toxicity, the identification of the target organ to obtain biological activity, toxicity linked to the expression of structurally altered proteins.”
It is necessary to insist pharmacokinetic studies be performed to determine how the body interacts with the administered substance during the entire duration of exposure—even though they are generally not required for vaccines unless there’s a new formulation or a vaccine contains novel adjuvants or excipients (inactive substances such as preservatives).
For GTPs, shedding studies are also needed to determine excretion and dissemination in the body, and biodistribution studies are needed to assess where injected compounds—such as lipid nanoparticles, the delivery system used to deliver mRNA—travel in the body and which tissues or organs they accumulate in.
After assessing Pfizer and Moderna’s COVID-19 vaccine documents obtained by attorney Aaron Siri through the Freedom of Information Act, Wiseman noted many studies listed in nonclinical summaries that should have been performed but were not.
“Several studies should have been done but weren’t done because they fell under the auspices of vaccines. But if you read the guidelines, it doesn’t say these studies are unnecessary, just that circumstances may deem them unnecessary,” Wiseman said. “We need laws for products that say you can’t just exclude them from regulations because you feel like it—because they are still gene therapies,” he said.”We are hijacking the machines of our bodies to produce spike proteins in an uncontrolled, undefined way—there are too many things we don’t know about.”
A correct label for the covid “vaccine” would be Bio-Weapon.
There was an official filing, I think it was ECC, with an AMerican regulatory agency managing commerce, in which the statement was made that the ‘vaccine’ was gene therapy but, to avoid people from associating that with some negative connotation, especially during a ‘pandemic’, the product would be marketed as a ‘vaccine’.
Former Pfizer employee Karen Kingston - vaxx part of a conspiracy to harm children..
Dr. Bryan Ardis had strong words for the FDA advisers who voted in favor of allowing the vaxx to be injected into children aged five to 11. “Shame on the FDA committee members who voted yes to inject five- to 11-year-old Americans. I actually am so disgusted. I think you’re all complicit in any murder of children who die from myocarditis as a result of this. Citizens in this country should hold you accountable,” he said.
Ardis mentioned that injecting children with the Pfizer vaccine goes against the precepts of the Nuremberg Code..
The code puts informed consent first and foremost .. Ardis pointed out: “Do you really think a five- to 11-year-old child has the ability to give you informed consent? Children are at zero risk of death from COVID-19
https://freerepublic.com/focus/news/4011543/posts
Thats what many of us correctly called them. Thats what they are.
Further proof was they, the fauci medical establishment types, HAD to alter the definition of what a vaccine was in order to after the fact call these abominations “vaccines”
Yeah, no duh. I’m getting vaccine-certified for my job (comes with a pay raise), I will NOT give those. Flu? Sure. Shingles? Okay. COVID? No way. Not vaccines.
They changed the definition of, “vaccine” to fit the COVID shots, but didn’t change, “gene therapy” to not. It still fits the definition of, “gene therapy”, whether they like it or not.
Bkmk
Correct term of the “vaccine” mRNA Covid 19 is TRANSFECT and “vaccination” process is called TRANSFECTION IN VIVO!
A Bio-Weapon Transfection
It’s a Gene Therapy, not a vaccine. They can call it a vaccine if they want, but it still meets the definition of, “Gene Therapy”, which means I’m not giving it.
Grave harm…from free speech!????!
Revenge of the Praetorian Guard!:
BY Brownstone InstituteBROWNSTONE INSTITUTE JULY 9, 2023 GOVERNMENT, LAW, TECHNOLOGY 8 MINUTE READ
There was no censorship, but it’s good that they censored misinformation.
Defenders of the Covid regime have adopted this Doublethink in response to Judge Terry Doughty’s recent injunction against the government’s collusion with Big Tech. As Orwell describes in 1984, they “hold simultaneously two opinions which cancel out, knowing them to be contradictory and believing in both of them.”
Consider the language of the Biden administration’s call for an “emergency stay” of the injunction from Missouri v. Biden that stops the government from telling social media companies what they should and should not allow their users to post.
The appeal says government is not censoring but must have the power to continue “working with social media companies on initiatives to prevent grave harm to the American people and our democratic processes.”
Grave harm…from free speech!
Harvard Law Professor Larry Tribe exemplifies this authoritarian advocacy. For decades, Tribe built a reputation as a legal scholar. He authored the country’s leading constitutional law treatise, advised presidents, and appeared on television as a legal commentator.
But age has a way of eroding veneers. Tribe is a defender of a political regime, a member of a Praetorian Guard comfortable with abolishing constitutional liberties when it advances his political preferences.
In the last three years, Tribe has argued that Russian President Vladimir Putin rigged the 2016 presidential election for “Thief in Chief, Donald Trump,” led the Justice Department to argue that the CDC eviction moratorium was constitutional, and successfully lobbied President Biden to unilaterally cancel student loans.
If he were on the other side of the aisle, Mr. Tribe might be accused of spreading misinformation and unconstitutional theories that threatened our democracy. Instead, he continues to serve as a mouthpiece for the country’s most powerful forces.
On Wednesday, Tribe co-authored an article with Michigan Law Professor Leah Litman attacking Judge Doughty’s injunction against the federal government’s collusive censorship of its political opponents. Their argument is notable for its false assertions of fact and improper implications of law. They remain obtuse to the allegations in the case, the principles of the First Amendment, and the historical ploys to overturn civil liberties. All the while, they maintain a posture of moral superiority that the Biden White House has mimicked.
A “Thoroughly Debunked Conspiracy Theory”
The professors begin their article with a false premise: “The impetus behind the case is the now thoroughly debunked conspiracy theory that the government is somehow strong-arming Big Tech into censoring conservative speech and speakers in violation of the First Amendment.”
They don’t offer an explanation for this description. They fail to address the documented censorship of Alex Berenson, Jay Bhattacharya, the Great Barrington Declaration, Robert F. Kennedy, Jr., and others. There is no mention of Facebook banning users who promoted the lab-leak hypothesis after working with the CDC, the Biden Administration’s public campaign urging social media companies to censor dissent in July 2021, or the Twitter Files’ documentation of the US Security State’s influence on Big Tech.
Instead, Tribe and Litman dismiss censorship as a thoroughly debunked conspiracy theory. They didn’t need to look far for examples – the opinion documents multiple instances of the coordination between Big Tech and the Biden White House in silencing opposition.
“Are you guys f**king serious?” White House Advisor Rob Flaherty asked Facebook after the company failed to censor critics of the Covid vaccine. “I want an answer on what happened here and I want it today.”
At other times, Flaherty was more direct. “Please remove this account immediately,” he told Twitter about a Biden family parody account. The company compiled within an hour.
His boss demanded Twitter remove posts from Robert F. Kennedy, Jr., writing: “Hey Folks-Wanted to flag the below tweet and am wondering if we can get moving on the process of having it removed ASAP.”
There are too many incidents to list, but it is clear that censorship was more than a thoroughly debunked conspiracy theory. Either Tribe did not read the decision, or his ideology blinded him from reality.
“A cesspool of disinformation”
The professors’ debunked conspiracy theory premise contradicts their position later in the article.
Like many of their peers, Tribe and Litman hold an incompatible set of views: on one hand, they argue that allegations of censorship are illusory. At the same time, they argue that the government is justified in suppressing speech because of the dangers of “disinformation.”
Censorship doesn’t exist, but it’s good that it does.
They write that the ruling incorrectly defends Americans’ right of “existing in a cesspool of disinformation about election denialism and COVID.” They hold that this is an incorrect application of the First Amendment. The natural corollary to their argument would be that the government is justified in censoring “disinformation.”
But the First Amendment does not discriminate against false ideas. Labeling speech “disinformation” or smearing it with associations about “election denialism” does not take away its constitutional protections.
“Under the First Amendment there is no such thing as a false idea,” the Supreme Court held in Gertz v. Welch. “However pernicious an opinion may seem, we depend for its correction not on the conscience of judges and juries, but on the competition of other ideas.” Tribe and Litman wouldn’t defer to the conscience of judges and juries – they would leave corrections to unelected White House bureaucrats.
“Some false statements are inevitable if there is to be an open and vigorous expression of views in public and private conversation,” the Court held in United States v. Alvarez. The Framers knew the dangers of central government acting as arbiters of truth, so they banned that form of informational totalitarianism. Now, Tribe and Litman advocate to overturn that system of liberty.
It “will make us less secure as a nation and will endanger us all every day”
The professors resort to the familiar campaign of conflating dissent with danger. Justice Oliver Wendell Holmes compared handing out leaflets opposing World War I to “shouting fire in a crowded theater.” The Bush Administration eroded civil liberties in the War on Terror through the false dichotomy: “Either you are with us or you are with the terrorists.” Now, Tribe resorts to national security hysteria in defending the assault on the First Amendment. “If left standing,” he writes, the injunction “will make us less secure as a nation and will endanger us all every day.”
The professors explicitly accuse Judge Doughty of endangering Americans. So what does the judgment demand that calls for this accusation? Judge Doughty’s order prohibits government actors from communicating with social media companies to censor “content containing protected free speech.” The Biden Administration can denounce journalists, give its own press briefings, and take advantage of the friendly media environment; it just can’t encourage private companies to censor constitutionally protected speech.
“It is also axiomatic that a state may not induce, encourage or promote private persons to accomplish what it is constitutionally forbidden to accomplish,” the Court held in Norwood v. Harrison. Judge Doughty applied that axiom to the digital age, and defenders of the regime have accused him of assaulting the republic.
The Biden Administration has adopted the same view as Tribe, writing in its appeal that the injunction hinders its ability to pursue “initiatives to prevent grave harm to the American people and our democratic processes.” Again, the language mimics Orwell’s description of Doublethink: “tohttps://docs.google.com/document/d/1q2Ah-evn1GDiWFfV241QRmsyBdrtbXlMOFL0Xmsu0Ns/edit believe that democracy was impossible and that the Party was the guardian of democracy
The appeal rests on the argument that the “immediate and ongoing harms to the Government outweigh any risk of injury to Plaintiffs.” Considering what Judge Doughty’s order prohibits, the Biden Administration is saying that the inability to work with social media companies to censor “content containing protected free speech” creates “immediate and ongoing harms” that outweigh Americans’ First Amendment liberties.
The Praetorian Guard
In sum, Tribe and Litman’s arguments are divorced from the facts of the case and the protections of the First Amendment. Their work is not legal scholarship; it is a defense of the regime. They advance unconstitutional agendas to pursue their political interests. More alarmingly, the White House has adopted their point of view.
Tribe is familiar with this tactic. He has promoted clearly unconstitutional programs related to the debt ceiling, student loans, and COVID because he agrees with their progressive aims. President Biden has enjoyed and followed Tribe’s advice in each initiative.
Tribe is not unfamiliar with the ramifications of censorship. “It would be a mistake to leave judgments about the ‘proper’ distribution of speech to politicians. Arming them with a roving license to level the playing field by silencing or adjusting the volume of disfavored speakers is an invitation to self-serving behavior and, ultimately, tyranny,” he wrote eight years ago. Now it is clear that he accepts, perhaps demands, tyranny provided it advances his political beliefs.
Maybe the tyrannical impulse is benign – Tribe may think abolishing the country’s constitutional guardrails would be best for the nation. The law, however, does not have a carve out for claims of moral pursuit.
In Robert Bolt’s A Man for All Seasons, Thomas More asks his son-in-law, William Roper, if he would give the Devil the protection of the law. Roper responds that he’d “cut down every law in England” to get to the Devil.
“Oh? And when the last law was down, and the Devil turned ’round on you, where would you hide, Roper, the laws all being flat?” More asks. “This country is planted thick with laws, from coast to coast, Man’s laws, not God’s! And if you cut them down… do you really think you could stand upright in the winds that would blow then? Yes, I’d give the Devil benefit of law, for my own safety’s sake!”
Tribe and the Biden Administration may think that they have a divine mission in censoring alleged misinformation, that the Devil’s reincarnation has taken multiple forms in the bodies of Tucker Carlson, RFK Jr., Alex Berenson, and Jay Bhattacharya. Woodrow Wilson had a devout certainty in his persecution of dissidents, as did George Bush in his War on Terror.
The self-professed nobility of their missions, however, does not excuse violations of Constitutional rights.
None of us ever wanted to live in a country in which the ruling regime openly expresses opposition to core constitutional rights that many generations of Americans thought were guaranteed by law. The injunction of Missouri v. Biden does nothing other than remind the government of those rights. And this is precisely why the Biden administration so strongly objects.
https://brownstone.org/articles/revenge-of-the-praetorian-guard/
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